Boston Scientific recalls CRE Pro Wireguided 15-18mm 240cm devices with potential sterile pouch breaches. Affected units have specific lot numbers and expiration dates. Consumers should contact the company for details.
Potential sterile breach of the pouches in which devices are packaged.
Boston Scientific is recalling certain CRE Pro Wireguided 15-18mm 240cm devices due to a potential sterile pouch breach in packaging. This could lead to contamination of the medical device before use, posing a risk of infection during procedures.
The packaging pouches for these medical devices may have been breached, potentially allowing contamination. If the device is used without proper sterility, it could cause infections during medical procedures.
Medical professionals using these devices for procedures are most at risk. Patients receiving these devices may face infection if the sterile packaging is compromised.
Check for the product name 'CRE Pro Wireguided 15-18mm 240cm' with specific lot numbers listed in the recall notice. The expiration dates are November 24, 2028, and March 26, 2029.
Reach out to Boston Scientific for specific details about your device and instructions on how to proceed.
The product is CRE Pro Wireguided 15-18mm 240cm.
Affected lot numbers include 38043116, 38192116, 38192117, 38192118, 38192119, 38192960, 38192961, 38214896, and many others as listed in the recall notice.
The expiration dates are November 24, 2028, and March 26, 2029.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2630-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2630-2026 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
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